FDA clears HeartBeam’s at-home arrhythmia assessment tool

HeartBeam’s ECG software duplicates the 12-lead ECG approach undertaken in healthcare settings with electrodes to evaluate heart arrhythmias.

eartBeam has secured US Food and Drug Administration (FDA) clearance for its 12-lead electrocardiogram (ECG) synthesis software, setting the arrhythmia assessment tool up for deployment in patients’ homes.

The company’s ECG system comes in the form of a credit card-sized device that patients hold to their chest to record the heart’s electrical signals. Known as vector electrocardiography (VECG), HeartBeam’s technology works by gathering 3D signals of the heart and converting them into a 12-lead ECG.

Via a companion smartphone app, once ECG recordings are captured, they get uploaded to HeartBeam’s cloud and are interpreted by ‘on-call’ cardiologists who then follow up with a patient.

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